Biomedical Engineering Reference
In-Depth Information
TABLE 6.7 FMEA for Pre-Phase 3 Manufacture and Control
Risk
Priority
Risk
Process
Failure
Failure
Failure
Occurrence Detection Severity Number Acceptable
Actions to Reduce
#
Step
Mode
Causes
Effects
[1-5]
[1-5]
[1-5]
(RPN)
Yes/No
Occurrence of Failure
9. All
Equipment
dirty
Failure of
cleaning
procedures
Contamination/
cross-
contamination
5
3
4
60
No
Disposable equipment
for sampling and
weighing, cleaning
procedures; line
clearance procedure
upgraded.
NOTE: company has
now introduced
additional APIs so risk
has greatly increased
12. Incoming
material
Materials
unsuitable
Material
OOS
Contaminated
product
2
2
4
16
No
On-site audit
Quality agreement with
supplier
Full COA testing with
validated methods
16. Shipping to
site
Lack of
adequately
controlled
procedures
Distribution of
product
inadequately
controlled
Poor quality
product
1
5
3
15
No
Use calibrated data
loggers to monitor
shipping
Qualify shipping process
21. QC
Lack of
adequately
controlled
procedures
QC procedures
unreliable
COA results lack
integrity
3
3
4
36
No
Validate methods
according to ICH
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